Events

Varian RPM System version 1.7.3 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Varian Medical Systems Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    45519
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0554-2008
  • 사례 출판 날짜
    2008-01-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-09-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65722
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Linear Medical Accelerator - Product Code IYE
  • 원인
    Erroneously resetting: rpm system version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. rpm 1.7 erroneously resets the phase-based gating thresholds to system default during the treatment session, if the user accesses the session options during the treatment session. this can lead to difference between the planned and delivered.
  • 조치
    Varian sent an Urgent Medical Device Correction letter on September 26, 2007, to all its direct consignees, informing them that the RPM version 1.7 may reset the phase thresholds if Sessions options are accessed during treatment. A Service Representative will be scheduling a visit to user site to perform the modification requested to address the problem, when a corrected software version is available.

Device

Varian RPM System version 1.7.3
  • 모델명 / 제조번호(시리얼번호)
    Serial Number:  H502244, H502211, H502203, H502183, H502179, H502178, H502169, H502167, H502166, H502154, H502152, H502138, H502137, H502136, H502133, H502132, H502131, H502130, H502126, H502121, H502119, H502118, H502117, H502116, H502112, H502110, H502107, H502104, H502103, H502102, H502096, H502060, H502057, H502045, H502002, H501999, H501983, H501930, H501907, H501904, H501869, H501838, H501577, H501412, H501367, H501329, H501325, H501306, H501290, H501259, H501246, H501222, H501214, H502051, H502067, H500395, H500406, H500853, and H502066
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide including countries of: Ireland, Italy, Spain, UK, Denmark, Finland, France, and Canada
  • 제품 설명
    Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models; Varian Medical Systems, Palo Alto, CA 94304
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc
  • 제조사 주소
    Varian Medical Systems Inc, 911 Hansen Way, Palo Alto CA 94304
  • Source
    USFDA